CA2944330A1 - Composition pharmaceutique liquide d'adalimumab - Google Patents

Composition pharmaceutique liquide d'adalimumab Download PDF

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Publication number
CA2944330A1
CA2944330A1 CA2944330A CA2944330A CA2944330A1 CA 2944330 A1 CA2944330 A1 CA 2944330A1 CA 2944330 A CA2944330 A CA 2944330A CA 2944330 A CA2944330 A CA 2944330A CA 2944330 A1 CA2944330 A1 CA 2944330A1
Authority
CA
Canada
Prior art keywords
formulation
adalimumab
buffer
pharmaceutical composition
antibody
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA2944330A
Other languages
English (en)
Inventor
Himanshu Gadgil
Chandresh CHHATBAR
Vijaykant PANDEY
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Intas Pharmaceuticals Ltd
Original Assignee
Intas Pharmaceuticals Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Intas Pharmaceuticals Ltd filed Critical Intas Pharmaceuticals Ltd
Publication of CA2944330A1 publication Critical patent/CA2944330A1/fr
Abandoned legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

La présente invention concerne une composition pharmaceutique liquide comprenant un anticorps anti-TNFa, un tampon, un agent stabilisant et un agent tensio-actif.
CA2944330A 2014-04-02 2015-02-18 Composition pharmaceutique liquide d'adalimumab Abandoned CA2944330A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN1248/MUM/2014 2014-04-02
PCT/IN2015/000092 WO2015151115A1 (fr) 2014-04-02 2015-02-18 Composition pharmaceutique liquide d'adalimumab
IN1248MU2014 IN2014MU01248A (fr) 2014-04-02 2015-02-18

Publications (1)

Publication Number Publication Date
CA2944330A1 true CA2944330A1 (fr) 2015-10-08

Family

ID=54239505

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2944330A Abandoned CA2944330A1 (fr) 2014-04-02 2015-02-18 Composition pharmaceutique liquide d'adalimumab

Country Status (5)

Country Link
US (2) US10688187B2 (fr)
EP (1) EP3125928A4 (fr)
CA (1) CA2944330A1 (fr)
IN (1) IN2014MU01248A (fr)
WO (1) WO2015151115A1 (fr)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2572919T3 (es) 2014-05-23 2016-06-03 Ares Trading S.A. Composición farmacéutica líquida
ES2607489T3 (es) 2014-05-23 2017-03-31 Ares Trading S.A. Composición farmacéutica líquida
EP2946765B1 (fr) * 2014-05-23 2016-08-31 Ares Trading S.A. Composition pharmaceutique liquide
AU2017287743C1 (en) * 2016-06-30 2020-10-01 Celltrion Inc. Stable liquid pharmaceutical preparation
JP7177777B2 (ja) * 2017-01-11 2022-11-24 セルトリオン， インク． 安定した液体製剤
MX2019010895A (es) * 2017-03-16 2019-11-05 Lg Chemical Ltd Formulacion liquida de anticuerpo anti-tnf alfa.
AU2020225202B2 (en) 2019-02-18 2023-10-26 Eli Lilly And Company Therapeutic antibody formulation
EP4037703A4 (fr) * 2019-10-02 2023-12-06 Alamab Therapeutics, Inc. Formulations d'anticorps anti-connexine

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5580856A (en) 1994-07-15 1996-12-03 Prestrelski; Steven J. Formulation of a reconstituted protein, and method and kit for the production thereof
HU228630B1 (en) 1996-02-09 2013-04-29 Abbott Biotech Ltd Use of human anti bodies that bind human tnf-alpha and process for inhibiting of human tnf-alpha activity
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
ES2477996T3 (es) 2000-08-11 2014-07-18 Chugai Seiyaku Kabushiki Kaisha Preparaciones estabilizadas que contienen un anticuerpo
WO2003072060A2 (fr) * 2002-02-27 2003-09-04 Immunex Corporation Preparation de polypeptides
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
NZ602498A (en) * 2007-11-30 2014-08-29 Abbvie Inc Protein formulations and methods of making same
TWI603739B (zh) * 2010-11-11 2017-11-01 艾伯維生物技術有限責任公司 具有增進高濃度之抗－ＴＮＦα抗體之液體調配物
MX352823B (es) * 2011-10-28 2017-12-04 Integritybio Inc Formulaciones de proteinas que contienen aminoacidos.
NZ629261A (en) * 2012-03-07 2017-08-25 Cadila Healthcare Ltd Pharmaceutical formulations of tnf-alpha antibodies
FR2994390B1 (fr) 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
KR102238677B1 (ko) * 2012-09-07 2021-04-12 코히러스 바이오사이언시즈, 인코포레이티드 아달리무맙의 안정한 수성 제형
EP2946765B1 (fr) 2014-05-23 2016-08-31 Ares Trading S.A. Composition pharmaceutique liquide
TW201636047A (zh) 2015-01-28 2016-10-16 麥博賽恩斯有限公司 抗－ＴＮＦ－α抗體之醫藥調配物

Also Published As

Publication number Publication date
EP3125928A1 (fr) 2017-02-08
IN2014MU01248A (fr) 2015-10-09
US10688187B2 (en) 2020-06-23
US20170106090A1 (en) 2017-04-20
US20200405864A1 (en) 2020-12-31
EP3125928A4 (fr) 2017-11-29
WO2015151115A1 (fr) 2015-10-08

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Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20191129

FZDE Discontinued

Effective date: 20220208